24 completed, 4 terminated, 1 withdrawn. 8 Phase 3, 6 Phase 1, 5 Phase 2, 1 Early Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 5, Terminated 3 |
| Phase 1 | 6 | Completed 4, Terminated 1, Withdrawn 1 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow Factor VII: new trials by email Literature Review of Factor VII trials Research Report on Factor VII
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Efficacy of FVIIa to Prevent Excessive Bleeding in Hemophilia Patients With Inhibitors Undergoing Major Surgery Coagulation Factor VIIa (Recombinant) - Hemophilia | Phase 3 | Terminated | Laboratoire français de Fractionnement et de Biotechnologies | 2 | 2024-06-07 | 2026-07-31 |
| Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors Eptacog alfa, activated - Hemophilia A With Inhibitor, Hemophilia B With Inhibitor | Early Phase 1 | Completed | AryoGen Pharmed Co. | 14 | 2020-12-29 | 2022-09-10 |
| Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern Eptacog alfa (activated), Standard of care - Severe Postpartum Haemorrhage | Completed | Novo Nordisk A/S | 225 | 2020-06-29 | 2021-01-29 | |
| LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures Coagulation Factor VIIa (Recombinant) - Hemophilia | Phase 3 | Completed | Laboratoire français de Fractionnement et de Biotechnologies | 12 | 2016-08-25 | 2022-02-25 |
| Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors CSL689, Eptacog alfa (activated) - Hemophilia A With Inhibitors, Hemophilia B With Inhibitors | Phase 2 / Phase 3 | Terminated | CSL Behring | 25 | 2015-07-23 | 2019-08-28 |
| A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan eptacog alfa (activated) - Congenital Bleeding Disorder, Glanzmann's Disease | Completed | Novo Nordisk A/S | 4 | 2014-10-07 | 2017-07-11 | |
| Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors Coagulation Factor VIIa (Recombinant) - Hemophilia A With Inhibitors, Hemophilia B With Inhibitors | Phase 3 | Completed | rEVO Biologics | 27 | 2014-04-01 | 2017-06-14 |
| Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects activated recombinant human factor VII, eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Withdrawn | Novo Nordisk A/S | 2014-03-01 | 2014-03-26 | |
| A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 6 | 2013-09-01 | 2014-11-14 |
| A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B rhFVIIa - Hemophilia | Phase 1 | Completed | rEVO Biologics | 15 | 2012-10-01 | 2013-07-30 |
| A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 BAY86-6150, eptacog alfa [activated] - Hemophilia A, Hemophilia B | Phase 2 / Phase 3 | Completed | Bayer | 10 | 2012-06-01 | 2015-07-01 |
| Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors vatreptacog alfa (activated), eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Phase 3 | Completed | Novo Nordisk A/S | 72 | 2011-07-01 | 2017-05-15 |
| A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Completed | Novo Nordisk A/S | 15 | 2011-04-01 | 2023-12-29 | |
| PROPACT: Retrospective Prophylaxis Patient Case Collection eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Completed | Novo Nordisk A/S | 86 | 2009-04-01 | 2017-01-09 | |
| Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany eptacog alfa (activated) - Congenital Bleeding Disorder, Congenital FVII Deficiency | Completed | Novo Nordisk A/S | 64 | 2008-06-01 | 2016-12-07 | |
| Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding eptacog alfa (activated), clopidogrel, placebo - Haemostasis, Healthy | Phase 1 | Terminated | Novo Nordisk A/S | 91 | 2008-05-01 | 2016-11-23 |
| Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Completed | Novo Nordisk A/S | 102 | 2008-03-01 | 2017-01-11 | |
| Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds eptacog alfa (activated), vatreptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A | Phase 2 | Completed | Novo Nordisk A/S | 51 | 2007-06-01 | 2017-03-07 |
| Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment warfarin, eptacog alfa (activated), placebo - Haemostasis, Healthy | Phase 1 | Completed | Novo Nordisk A/S | 127 | 2007-01-01 | 2016-11-25 |
| Treatment of Inherited Factor VII Deficiency plasma derived Factor VII, recombinant FVIIa, Fresh Frozen Plasma - Factor VII Deficiency | Completed | University of L'Aquila | 223 | 2007-01-01 | 2012-11-27 |
Showing 20 of 29. Sign in to see all of them.
Hemophilia A (7) · Hemophilia B (4) · Cerebral Hemorrhage (2) · Thrombasthenia (2) · Factor VII Deficiency (1) · Postpartum Hemorrhage (1) · Wounds and Injuries (1)
Novo Nordisk A/S (21) · Laboratoire français de Fractionnement et de Biotechnologies (2) · rEVO Biologics (2) · AryoGen Pharmed Co. (1) · Bayer (1) · CSL Behring (1) · University of L'Aquila (1)
United States (16) · Italy (9) · United Kingdom (9) · Japan (8) · South Africa (8) · France (7) · Spain (7) · Germany (6) · Brazil (5) · Netherlands (5) · Poland (5) · Russia (5) · Thailand (5) · Turkey (Türkiye) (5) · Croatia (4)
Jean Francois Schved, MD (1) · Johan Frieling, MD,PhD (1) · Massimo Iacobelli, MD (1) · Miguel Escobar, MD (1)
PMID 18580208, PMID 37870112, PMID 40674256, PMID 17906567, PMID 18081834, PMID 18480205, PMID 22470921, PMID 23403322, PMID 24763923, PMID 40765904
2004 (1), 2005 (1)